(114 days)
The Truly TET-350 TET-370 is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal , pediatric and adult population used in the home setting.
Truly Infrared Ear Thermometer TET-350 TET-360 TET-370
The provided document is a 510(k) summary for an Infrared Ear Thermometer. It does not contain a study report or detailed information about acceptance criteria and device performance based on a study.
Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on the device's classification, substantial equivalence to a predicate device, and regulatory approval. It does not include specific performance data or study details.
To answer your request, a study report detailing performance metrics would be necessary.
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.